Early should mean early.
Leveraging AI and a urine-based approach designed to accurately detect stage 1 & 2 cancers.
Toby Oncology’s platform is currently in clinical validation and is not yet available for routine clinical use.
96%+
Accuracy detecting stage 1 & 2 cancers across the 10 most common cancers*
Early Changes Everything
Nearly 3 billion people worldwide are over 40, the age when cancer risk accelerates, yet we still don’t have simple, multi-cancer early detection, and most of the deadliest cancers have no routine screening.
– Cancer.org
OUTCOME
Detect cancer before it spreads
When cancer is found before it spreads, five-year survival is close to 90%. After it spreads, it falls to about 20%.
Source: SEER data
Problem
Most deadly cancers aren’t screened for
Only five cancers have routine screening. Cancers behind ~70% of deaths don’t have a recommended test.
Source: ACS and multi-cancer early detection background analyses of screened vs. unscreened cancers (~70% of cancer deaths from cancers without screening).
Vision
Early detection
has to be easy If early detection is complicated or invasive, most people won’t get it.
Our Goal
To make multi-cancer screening as simple as a urine sample during a routine doctor visit.
Our platform
Our platform turns a simple urine sample into early-stage insight
Toby Oncology has developed a urine-based, multi-cancer detection platform that reads tiny chemical signals in urine and uses AI to look for patterns linked to cancer, especially in its earliest stages.
From simple sample to signal
During a routine visit, a standard urine sample is collected and processed in the lab. Instruments measure chemical signals, and our AI models analyze the pattern to look for signals that may indicate cancer.
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Collect
A standard urine sample, like any routine lab test.
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Prepare
The sample is processed using established/common lab methods.
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Measure
Instruments capture the chemical fingerprint in the sample.
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Analyze
AI models look for patterns linked to cancer signals.
Built to see cancer at its earliest stages
The platform is designed to detect cancers at stages 1 and 2, before symptoms appear and when treatment can be most effective. Early internal studies show high accuracy detecting cancer in these earliest stages.*
Designed for real-world labs and everyday care
Our approach is urine-based benefitting from standard handling and storage, built to run on common lab equipment, so it can fit into existing workflows. The goal is to keep per-test complexity low enough to make multi-cancer screening part of routine care, not a rare specialty test.
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Uses standard handling, storage, and lab equipment
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Fits into existing lab workflows
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Built for routine screening and follow-up
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Designed to be affordable, not a rare specialty test
Evidence and validation
Backed by science and recognized by leading institutions
Our platform is grounded in years of research, clinical collaboration, and early studies using real patient samples and protected by a growing IP portfolio, including 14 patents filed to date.
30+ peer-reviewed studies validating urine-based VOC biomarkers for cancer detection
Early internal studies across hundreds of patient samples and multiple cancer types
Independent external blinded study outperforming currently available alternatives
FDA Breakthrough Device Designation for MCED across all 10 of the most common cancers
Who we’re building for
Built for patients, clinicians, and partners
Patients and families, clinicians and health systems, labs and life sciences teams, and innovators and investors all stand to benefit when cancer is found earlier, more simply, and at a cost that can scale.
Patients & families
People who want cancer found earlier, treated earlier, and feared less.
Clinicians & health systems
Care teams who need tools that fit everyday workflows and help catch cancer sooner.
Labs, life sciences & pharma partners
Labs and life sciences partners seeking multi-cancer signals for trials and monitoring.
Innovators & investors
Innovators and investors backing a new standard in early, accessible cancer detection.
What’s new from Toby Oncology
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TOBY Appoints Healthcare Leader Matthew Collier as Independent Director
As an independent director, Collier will provide objective oversight and strategic guidance as TOBY advances its groundbreaking technology toward commercialization.
Read Now -
TOBY receives FDA Breakthrough Device Designation (April 2025)
TOBY's test provides a painless, low-cost alternative—analyzing volatile organic compounds (VOCs) in a single urine sample using gas chromatography–mass spectrometry and proprietary AI to generate a real-time cancer risk score.
Read Now
Next Steps
Let’s move early detection into everyday care
Clinicians, labs, life sciences partners, and investors—connect with us to explore trials, deployments, and collaboration opportunities.